BEUDAMED
    FDA 510(k) FDA unclassified Substantially Equivalent 🇺🇸 United States

    SYNTHES HEMOSTATIC BONE PUTTY

    K Number: K113079 · Decision Dec 13, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34
    Same Product Code
    41
    Applicant Total
    1
    Review Days
    57

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    Basic Information

    Device Name
    SYNTHES HEMOSTATIC BONE PUTTY
    K Number
    K113079
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Synthes (Usa) Products, LLC/Norian Corporation
    Date Received
    October 17, 2011
    Decision Date
    December 13, 2011
    Product Code
    MTJ
    Advisory Committee
    Unknown
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MTJ Wax, Bone

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